Role of GMO Detection Methods in Trade - Impacts, Implicationsmethods.aaccnet.org/hidden/croplife/presentations...•A GMO traceability process or an IP system is not required •GMO

Global Detection Methods and Reference Materials Symposium

Anne Bridges, AACC Intl

CropLife International, 15th - 16th October 2015

Minneapolis, Minnesota, U.S.A

Role of GMO Detection Methods in Trade - Impacts, Implications

formerly the American Association of Cereal Chemists

• Global association of more than 2,000

scientists and food industry professionals from 70 countries

• Working to advance the understanding and knowledge of grain science Wheat, barley, rye … oats, rice, corn Pulses, ancient grains

• Product development, research, leadership, education, analytical methods, superior technical service, and advocacy

Trade – description

• What is trade – USA 2014 exports total = $1,402,282 x 106

USA export agriculture = $150,466 x 106 = 11 % of Total *

USA import agriculture = $38,734 x 106

• Obligations of export and buyer

• Managed – by contract

• What components of agriculture trade can be measured? e.g. Quality, Food Safety, Contaminants, GMOs

• Sampling and Testing is important - Sampling is critical

• Test methods – speed, precision and accuracy

• Need the same result everywhere

* US Economic Research Service

Codex Alimentarius - trade

• The C O D E X A L I M E N T A R I U S international food standards, guidelines and codes of practice contribute to the safety, quality and fairness of this international food trade. Consumers can trust the safety and quality of the food products they buy and importers can trust that the food they ordered will be in accordance with their specifications.

Top 30 U.S.A. Agricultural Sources, 2012-14 average

Source: USDA Economic Research Service

Exports

Imports

USA Agriculture Trade

World Grain System Characteristics • Most grain used for food, feed or processing is shipped

by bulk handling systems

• Bulk system is characterized by high volumes which achieve lower costs (economy of scale)

• Most of the world grain is used as feed – 72% of world corn production

– 60% of world oilseed production

• Specialty programs (value added rice, sweet corn, non GMO) need to function within this bulk handling infra structure

Quality Attributes Protein, Ash, Moisture,

Oil Profile etc(Validated Methods)

Contamination

Sampling and Testing

3rd party analysis/audits

Standards (Regulations and Safety)

Management

Timing

Cost (terms/conditions)

International Contracts and Regulations

Supply Chain

Bulk Handling of Grain - USA

Sampling and testing at each transfer – to grain contract

In 2013, GMO crops were grown, imported and/or used in field trials in 70 countries

Regulatory requirements are not harmonized globally Data requirements differ between countries

• Most are based on Codex Guideline for the Conduct of

Food Safety Assessment of Foods Derived from rDNA

Plants

• Some go beyond the Codex requirements

• Some trading blocks have very defined requirements

• Some countries are cooperating on assessments

• Politics can hold up or prevent approval

Regulatory requirements are not harmonized globally Countries have differing approaches to regulating biotech products

• Single events vs. stacked events

• Food, Feed or Processed Food labelling

• Import for laboratory use

• Movement between states

• Authorized versus unauthorized events

• LLP policies How does testing fit into the regulatory framework?

GMOs - categories, conditions and relative impact on trade • Approval process

• Risk assessment

• Labeling policies

• Traceability requirements

• Coexistence guidelines

• Membership in international agreements

• Exclusion of unapproved events

Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202

GMOs - categories, conditions and relative impact on trade • Approval process

• Risk assessment

• Labeling policies

• Traceability requirements

• Coexistence guidelines

• Membership in international agreements

• Exclusion of unapproved events

Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202

How does testing fit into a regulatory framework?

Some countries

Generally, testing for ‘GMO’ is not required…

• because biotech derived crops and their products are not considered substantially different from the conventional counterparts

• and most corn, soy, canola and cotton are Biotech-derived.

In these countries, testing is carried out only for export and specialist markets (such as organic, or produced without GMOs)

How does testing fit into a regulatory framework?

In other countries

Generally testing for GMOs or proof of lack of GMO is required even if the GMO cannot be detected (e.g. oils)

Although some countries exclude these products

• these countries are generally importers of food

In these countries, testing is carried out on imports as they come into the country, and in some cases on processed foods

Some actively seek cases of non-compliance

GMOs - categories, conditions and relative impact on trade • Approval process

• Risk assessment

• Labeling policies

• Traceability requirements

• Coexistence guidelines

• Membership in international agreements

• Exclusion of unapproved events

Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202

Labeling policies

• A label is not required or is just at proposal stage

• Voluntary GMO labelling

• Mandatory GMO label without threshold or with threshold >= 5%

• Mandatory GMO label with threshold <= 0.9%

• Countries declared GMO free

• Challenge - what determines the threshold?

Is there a safety or scientific basis for thresholds – at what level?

• Labeling thresholds at 0.9%

– It is “less than 1%”

• 0 % threshold for LLP

– Does it consider the safety of the technology?

– Or the limits of sampling?

– Or the cost of testing to zero?

Market verses Safety

GMOs - categories, conditions and relative impact on trade • Approval process

• Risk assessment

• Labeling policies

• Traceability requirements

• Coexistence guidelines

• Membership in international agreements

• Exclusion of unapproved events

Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202

Traceability requirements

• A GMO traceability process or an IP system is not required

• GMO traceability process is at proposal stage, or an IP system is in place

• Mandatory GMO traceability

• Countries declared GMO free

• Challenge to testing

• Oils and fats, sugar etc.

GMOs - categories, conditions and relative impact on trade • Approval process

• Risk assessment

• Labeling policies

• Traceability requirements

• Coexistence guidelines

• Membership in international agreements

• Exclusion of unapproved events

Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202

Introduction of New Events Accelerating • In the first 13 years, 30 events were

commercialized

• In 2009-2015, it was expected that 90 events would be commercialized *

Examples: by 2015, 24 corn and 17 soybean events

• These events will be used in stacked products and are treated as new events by some regulatory systems

• Brazil 2012: 33 approved traits

• 5 soybean, 18 maize, 9 cotton, 1 bean * Stein & Rodríguez-Cerezo 2010

Changes in origin of event development and commercialisation • By 2015, a number of commercial events will come

from South America and Asia and some will be for domestic markets/cultivation

• Asynchronous approvals are likely to increase

– Increased emergence of regionally approved events

– Zero Tolerance Policy becomes more of a problem

• Pragmatic Low Level Presence thresholds will be important in order to avoid major trade disruptions

Argentina announcement - 05 Octubre 2015

• soybean resistant to drought • potato resistant to virus PVY

Low Level Presence (LLP) • Refers to incidental small amounts of

biotech material that has been authorised in at least one country of cultivation, but is not authorised in the importing country

• Contributing factors

– Asynchronous approvals

– Unpredictable and politicized regulatory frameworks

Global trade • Seed is used to produce grain and other agricultural

commodities

• Traded around the world

• Different regulatory systems and approvals

• Different detection methods and thresholds

• Harmonised approach to testing can help global trade

Thank you

http://www.gipsa.usda.gov/fgis/commgallery/gr_srw.aspx